Intramuscular Temperature on the Echo-textural Characteristics

Healthy Subjects Clinical Trial

Official title:

Influence of Intramuscular Temperature on the Textural Characteristics of the B-mode Ultrasound Image.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145646
• Other study ID #: CEEI23_453
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Cardenal Herrera University
• Contact: Javier Molina-Payá, PhD
• Phone: 965426486
• Email: francisco.molina[@]uchceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Echointensity and echotexture have been used as a physiological marker for changes in skeletal muscle quality and structure caused by physical training, low activity, ageing and some neuromuscular disorders. However, there are some influencing factors on muscle echo-intensity and echotexture, such as temperature, which may not be taken into account when performing an ultrasound assessment and may alter the results.

This study aims to investigate the effects of muscle temperature on echointensity and other 2nd order echotextures variables such as homogeneity, contrast, correlation and entropy of muscle tissue, in order to gain a better understanding of this correlation and minimise its influence, which would allow greater precision in the use of muscle ultrasound as a diagnostic tool.

The methodology of this study includes firstly the acquisition of ultrasound images of the vastus lateralis muscle. This acquisition will be performed during the continuous recording of muscle temperature, carried out during a passive cooling process after 20 min of heating using microwave equipment. In addition, to standardise the results, a correction factor will be calculated to compensate for the influence of subcutaneous adipose tissue thickness on echogenicity and echotexture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acceptance of participation in the study.

• Healthy subjects.

• Subjects between the ages of 18 and 65.

Exclusion Criteria:

• Have known neurological, cardiovascular, metabolic or orthopedic conditions that prevent them from participating in the study.

• Present metal implants in the heating area.

• Wear a pacemaker.

• Perform physical activity during the 48 hours prior to data collection.

• Contraindications of dry needling such as: Belonephobia, history of abnormal reaction to the puncture or injection, anticoagulant treatment or thrombocytopenia, lymphedema over the area of intervention, severely compromised immune system, vascular diseases, diabetes mellitus, pregnancy, epilepsy, allergy to metals or that the intervention area has wounds, scars, tattoos, or stains.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Muscle warm-up
Passive heating of the vastus lateralis of the right quadriceps will be performed using a microwave device. The device will be set at a power of 150 W and a distance of 10-15 cm from the skin surface for 20 minutes with the purpose of increasing local muscle temperature to 40 ºC.

Locations

Country	Name	City	State
Spain	Sergio Montero Navarro	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Akima H, Yoshiko A, Tomita A, Ando R, Saito A, Ogawa M, Kondo S, Tanaka NI. Relationship between quadriceps echo intensity and functional and morphological characteristics in older men and women. Arch Gerontol Geriatr. 2017 May-Jun;70:105-111. doi: 10.1016/j.archger.2017.01.014. Epub 2017 Jan 20. — View Citation

Kenny GP, Reardon FD, Zaleski W, Reardon ML, Haman F, Ducharme MB. Muscle temperature transients before, during, and after exercise measured using an intramuscular multisensor probe. J Appl Physiol (1985). 2003 Jun;94(6):2350-7. doi: 10.1152/japplphysiol.01107.2002. Epub 2003 Feb 21. — View Citation

Pillen S, Tak RO, Zwarts MJ, Lammens MM, Verrijp KN, Arts IM, van der Laak JA, Hoogerbrugge PM, van Engelen BG, Verrips A. Skeletal muscle ultrasound: correlation between fibrous tissue and echo intensity. Ultrasound Med Biol. 2009 Mar;35(3):443-6. doi: 10.1016/j.ultrasmedbio.2008.09.016. Epub 2008 Dec 10. — View Citation

Pinto MD, Silveira Pinto R, Nosaka K, Blazevich AJ. Do Intramuscular Temperature and Fascicle Angle Affect Ultrasound Echo Intensity Values? Med Sci Sports Exerc. 2023 Apr 1;55(4):740-750. doi: 10.1249/MSS.0000000000003082. Epub 2022 Nov 8. — View Citation

Teixeira CA, Alvarenga AV, Cortela G, von Kruger MA, Pereira WC. Feasibility of non-invasive temperature estimation by the assessment of the average gray-level content of B-mode images. Ultrasonics. 2014 Aug;54(6):1692-702. doi: 10.1016/j.ultras.2014.02.021. Epub 2014 Mar 1. — View Citation

Young HJ, Jenkins NT, Zhao Q, Mccully KK. Measurement of intramuscular fat by muscle echo intensity. Muscle Nerve. 2015 Dec;52(6):963-71. doi: 10.1002/mus.24656. Epub 2015 Sep 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle echointensity (0-255 a.u.).	Muscle echointensity is calculated by the mean gray level value of the muscle Range of Interest (ROI). (0-255 a.u.)	During intervention
Primary	Muscle echovariance (0-255 a.u.).	The echovariance is determined by the relationship between the standard deviation and the average pixel intensity obtained from the histogram of the muscle ROI. (0-255 a.u.)	During intervention
Primary	Muscle energy or second angular momentum.	It is a second order parameter (GLCM) that measures textural uniformity of the muscle ROI	During intervention
Primary	Muscle homogeneity.	It is a second-order parameter (GLCM) that measures the uniformity of the muscle ROI composition.	During intervention
Primary	Contrast.	It is a second-order parameter (GLCM) that measures local variations in gray levels of the muscle ROI.	During intervention
Primary	Textural Correlation.	It is a second-order parameter (GLCM) that expresses linear gray-level dependencies of the muscle ROI.	During intervention
Primary	Entropy.	It is a second-order parameter (GLCM) to measure muscle ROI disorder.	During intervention
Primary	Echointensity correction factor for adipose thickness	The measurement of subcutaneous adipose thickness will be carried out through the average of the distance from the skin to the aponeurosis coinciding with the superficial interface of the muscle and with different pressures of the probe on the skin. This measure will be used to develop a correction factor that allows compensating the influence of this variable on echogenicity and echotexture, standardizing the results.	Pre-intervention
Primary	Muscle temperature (ºC).	Measurement of intramuscular temperature of the right vastus lateralis of the quadriceps (ºC)	Pre-intervention and during intervention
Secondary	Age (years)	Subject's age (years)	Pre-intervention
Secondary	Sex (female or male)	Subject's sex (female or male)	Pre-intervention
Secondary	Dominance	Dominant leg (right-left)	Pre-intervention
Secondary	Body mass index	It is a measure of body fat based on height and weight that applies to adult men and women	Pre-intervention

External Links

•   Description The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain